FDA.reportPublic FDA data

FIRST SIGN®

Primary DI
00857338006552
Brand
FIRST SIGN®
Company
HEMOSURE INC.
Model
FSCWMA-25
Catalog number
FSCWMA-25
Device description
DOA Single Test Dip card, 25Pcs/Box; First Sign for HemosuremAMP
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DJCThin Layer Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857338006552PrimaryGS10
00841824100060Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857338006552008573380065528573380065520857338006552
00841824100060008418241000608418241000600841824100060

GMDN Terms#

Term, Definition table
TermDefinition
Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of a specific methamphetamine in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806777541
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817763022527First Sign®FSCCUP-13124 W/AD7FSCCUP-13124 W/AD72024-10-16
00817763022510First Sign®FSCCUP-13124 W/AD7FSCCUP-13124 W/AD72024-10-16
00817763022831First SignFSCCUP-21124FSCCUP-211242023-07-05
00817763022824First SignFSCCUP-21124FSCCUP-211242023-07-05
00857338006217First SignF2-CT25CF2-CT25C2016-05-09
00857338006224First Sign®F1-CT25UF1-CT25U2016-08-01
00857338006262HEMOSUREF2-TC01F2-TC012017-06-30
00857338006330First Sign®F2-CT25CF2-CT25C2016-08-01
00817763021933First Sign®F1-ST25F1-D042017-11-08
00817763021964Ovultell®F5-OST20/2F5-OST20/22017-11-13
00817763022367First SignFSCDIP1464FSCDIP14642023-05-18
00857338006576FIRST SIGN®FSCWTH-25FSCWTH-252016-08-01
00817763020837FIRST SIGN®FSCDIPTH-25FSCDIPTH-252016-10-07
00817763022589FIRST SIGN®FSCDIP7364FSCDIP73642022-04-21
00817763022442FIRST SIGN®FSCDIP3384FSCDIP33842019-05-14
00817763022541First Sign®FSCDIP7164FSCDIP7164P2020-01-08
00817763022466First Sign®FSCCUP-13124 W/ADFSCCUP-13124 W/ADP2019-10-21
00817763022428FIRST SIGN®FSCCUP-3864FSCCUP-38642019-04-29
00857338006019Hemosure T1-CK30T1-CK302016-05-09
00857338006026HEMOSURE®T1-CK10T1-CK102016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
00194346667574EquateWAL-MART STORES, INC.DJC2026-04-07
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.DJC2024-02-09
16936983149744Discover milti-drug 7 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.DJC2024-02-08
16936983150634Discover milti-drug 8 drugs rapid test cup (urine)Hangzhou AllTest Biotech Co., Ltd.DJC2024-02-08
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.DJC2023-11-30
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDJC2023-04-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-05-28
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJC2020-06-18
10722066005139Rapid ResponseBTNX IncDJC2020-06-03
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2020-05-29
10722066005108Rapid ResponseBTNX IncDJC2020-02-12
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDJC2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2019-02-12
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-07-05
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-05-23
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-02-13